Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 5, 2000
Last updated: June 20, 2013
Last verified: August 2002

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.

Condition Intervention Phase
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Study Completion Date: September 2006
Detailed Description:


  • Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide.
  • Determine the toxic effects of induction arsenic trioxide in this patient population.

OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week).

Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Morphologically proven acute lymphoblastic leukemia (ALL)

    • Subtypes L1, L2, or L3
    • Bone marrow morphology with greater than 25% lymphoblasts
    • ALL morphology and cytochemistry with myeloid markers eligible
  • Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation

    • Any number of prior relapses allowed
    • No relapse following allogeneic transplantation
  • Prior CNS leukemia allowed if treated and currently disease-free



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN


  • Creatinine no greater than 2 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant active infection
  • No other medical conditions that would likely decrease life expectancy
  • No other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • At least 2 weeks since prior systemic corticosteroids


  • Not specified


  • Not specified


  • No concurrent antibiotics for active or resolving infection
  Contacts and Locations
Please refer to this study by its identifier: NCT00006008

  Show 71 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Study Chair: Mark R. Litzow, MD Mayo Clinic
  More Information

Additional Information:
Publications: Identifier: NCT00006008     History of Changes
Other Study ID Numbers: CDR0000068016, E-9998
Study First Received: July 5, 2000
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute lymphoblastic leukemia
L1 adult acute lymphoblastic leukemia
L2 adult acute lymphoblastic leukemia
L3 adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 23, 2014